A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency
NCT ID: NCT06024967
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2023-12-01
2025-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GenSci004
PEG-somatropin
PEG-somatropin
Interventions
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PEG-somatropin
PEG-somatropin
Eligibility Criteria
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Inclusion Criteria
2. Participant must be 6 months to 17 years old
3. Tanner stage \<5 at Visit 1
4. Open epiphyses
5. Normal fundoscopy at Screening
6. Written, signed, informed consent of the participant's parent(s)/LAR(s) and written assent of the participant
Exclusion Criteria
2. Children with diabetes mellitus
3. Major medical conditions and/or presence of contraindications to GH treatment
4. Pregnancy
5. Participation in any other study of an investigational agent within three months prior to Visit 1
6. Prior exposure to investigational drug or any other long-acting growth hormone
7. Any other reason per investigator's discretion
6 Months
17 Years
ALL
No
Sponsors
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Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lawrence Silverman, MD
Role: STUDY_CHAIR
Morristown Medical Center
Central Contacts
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Other Identifiers
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GenSci004-302
Identifier Type: -
Identifier Source: org_study_id
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